The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Vuepoint Ii Oct System.
Device ID | K150474 |
510k Number | K150474 |
Device Name: | NuVasive VuePoint II OCT System |
Classification | Posterior Cervical Screw System |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Cynthia Adams |
Correspondent | Cynthia Adams NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-23 |
Decision Date | 2015-10-21 |
Summary: | summary |